Skip to content

Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management

Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04556097
Acronym
CRESCENT
Enrollment
524
Registered
2020-09-21
Start date
2020-12-15
Completion date
2021-11-03
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia

Brief summary

There is growing need for to provide high quality care for persons living with dementia (PLWD) and provide support for care partners in the primary care setting. The Care Ecosystem model is a telephone-based dementia care program that provides standardized, proactive, personalized, and scalable support and education for care partners. The Care Ecosystem model has demonstrated an improvement in patient quality of life, reduced unnecessary healthcare expenditures, and a decrease in care partner burden and depression. In this pilot the investigators will assess the feasibility of implementing and measuring outcomes of an adapted Care Ecosystem training model for primary care nurse managers serving a diverse panel of PLWD and their care partners in primary care practices participating in the Mass General Brigham healthcare system's Integrated Care Management Program in Boston, MA. The study team will leverage the Mass General Brigham electronic medical record to determine the feasibility of collecting the primary clinical outcome defined as emergency department visits among the PLWD cared for by the primary care practices. The investigative team will also assess the feasibility of implementation, number of contacts between nurse care managers and care partners, and documented advance care planning.

Interventions

BEHAVIORALCare Ecosystem

The Care Ecosystem model uses a telephone-based intervention to support persons with dementia and their care partners, screening for common dementia-related problems and providing modular standardized support protocols and caregiver education. Specially trained health care navigators systematically identify needs and address health status, advance care planning, medication management and management of challenging behaviors. Health care navigators receive backup support from a nurse, social worker, dementia specialist, and pharmacist, and maintain close communication with the primary care provider of the persons with dementia. This Care Ecosystem model will be adapted to augment the dementia care provided by experienced Integrated Care Management Program nurse care managers engaged in the care of high-risk, high-cost patients in a large health system.

Sponsors

Mclean Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Medicare beneficiary aligned to the Partners Medicare ACO * ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020 (excluding diagnoses for diagnostic testing services) * Actively engaged in care management services with a nurse care manager enrolled in the study

Exclusion criteria

\- Permanent resident of long-term care or deceased at the start of the study

Design outcomes

Primary

MeasureTime frame
ED Visits Per Member Per Month 6 Months Post Intervention6 months

Secondary

MeasureTime frameDescription
Caregiver Distress (NPI-Q) 6 Months Post6 monthsMean Neuropsychiatric Inventory Questionnaire (NPI-Q) distress score at 6-month follow-up survey. The NPI-Q distress scale assesses caregiver distress. Scores can range from 0 to 60 and higher scores indicate greater distress.

Countries

United States

Participant flow

Pre-assignment details

This is a pragmatic trial where nurse managers at various primary care practices were randomized to the control group which had delayed training or the intervention group which was the early intervention training. The enrollment number in the protocol section conflicts with the number of participants started in the flow module as some patients without a designated caregiver, who were deceased or who had moved to a skilled nursing facility were excluded.

Participants by arm

ArmCount
Intervention- PWD
Persons with Dementia Intervention: Patients of nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021.
126
Control- PWD
Persons with Dementia Control: Patients of nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021.
105
Intervention- NCM
Nurse Care Managers Intervention: Nurse care managers who received adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020.
14
Control- NCM
Nurse Care Managers Control: Nurse care managers who did not receive adapted Care Ecosystem training in December 2020 and January 2021. Their patients are persons with dementia and their primary caregiver under the care of these nurse care managers were defines as Medicare beneficiaries aligned to the Mass General Brigham Medicare ACO with an ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019, and July 31, 2020.
15
Total260

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyDeath0500
Overall StudyDid not have at least 1 member month in pre and post period17800
Overall StudyIneligible, health3400
Overall StudyIneligible, language0100
Overall StudyIneligible, no longer in care management0210
Overall StudyIneligible, SNF2200
Overall StudyMissing identifier2400
Overall StudyNo caregiver435300
Overall StudyNo dementia13300

Baseline characteristics

CharacteristicControl- PWDIntervention- PWDControl- NCMIntervention- NCMTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
100 Participants126 Participants0 Participants0 Participants226 Participants
Age, Categorical
Between 18 and 65 years
5 Participants0 Participants15 Participants14 Participants34 Participants
Age, Continuous82.88 years
STANDARD_DEVIATION 9.37
84.83 years
STANDARD_DEVIATION 8.17
83.94 years
STANDARD_DEVIATION 8.77
ED Visits Per Member Per Month0.052 Visits per member per month
STANDARD_DEVIATION 0.08
0.060 Visits per member per month
STANDARD_DEVIATION 0.158
0.057 Visits per member per month
STANDARD_DEVIATION 0.128
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants19 Participants0 Participants0 Participants25 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
97 Participants103 Participants0 Participants0 Participants200 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants4 Participants15 Participants14 Participants35 Participants
NPI-Q Distress Score9.29 Score on a scale
STANDARD_DEVIATION 6.41
11.17 Score on a scale
STANDARD_DEVIATION 9.27
10.33 Score on a scale
STANDARD_DEVIATION 8.12
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants9 Participants0 Participants0 Participants12 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants24 Participants15 Participants14 Participants61 Participants
Race (NIH/OMB)
White
94 Participants93 Participants0 Participants0 Participants187 Participants
Region of Enrollment
United States
105 participants126 participants15 participants14 participants231 participants
Sex: Female, Male
Female
68 Participants82 Participants13 Participants12 Participants175 Participants
Sex: Female, Male
Male
37 Participants44 Participants2 Participants2 Participants85 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
21 / 12614 / 1050 / 140 / 15
other
Total, other adverse events
0 / 1260 / 1050 / 140 / 15
serious
Total, serious adverse events
0 / 1260 / 1050 / 140 / 15

Outcome results

Primary

ED Visits Per Member Per Month 6 Months Post Intervention

Time frame: 6 months

Population: The analysis population for the primary outcome of Emergency Department visits includes all patients eligible for the baseline survey who had at least 1 member month during pre-intervention and post-intervention.

ArmMeasureValue (MEAN)Dispersion
InterventionED Visits Per Member Per Month 6 Months Post Intervention0.056 Visits per member per monthStandard Deviation 0.129
ControlED Visits Per Member Per Month 6 Months Post Intervention0.075 Visits per member per monthStandard Deviation 0.144
p-value: 0.0595% CI: [0.31, 1.2]Difference in differences
Secondary

Caregiver Distress (NPI-Q) 6 Months Post

Mean Neuropsychiatric Inventory Questionnaire (NPI-Q) distress score at 6-month follow-up survey. The NPI-Q distress scale assesses caregiver distress. Scores can range from 0 to 60 and higher scores indicate greater distress.

Time frame: 6 months

Population: The analysis population for the outcome of NPI-Q Distress among caregivers for persons with dementia was restricted only to those who completed the baseline and 6-month follow-up surveys (Intervention, N=35; Control, N=28).

ArmMeasureValue (MEAN)Dispersion
InterventionCaregiver Distress (NPI-Q) 6 Months Post10.86 Score on a scaleStandard Deviation 8.79
ControlCaregiver Distress (NPI-Q) 6 Months Post11.68 Score on a scaleStandard Deviation 8.6
p-value: 0.0595% CI: [-6.53, 1.12]Difference in differences

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026